GxP-Regulated Archives and the GxP Archivist

The primary focus of this course is on the implementation of archive procedures within an organisation and the operation of an archive in compliance with GxP (GLP, GCP, GMP). Previously, separate courses were offered for GLP Archivists and for GCP Archivists. The courses have now been combined into a single course as 90% of the content was the same for both courses. It is also beneficial for professional development to understand how GLP and GCP requirements differ from each other and from other requirements. The principles of archiving covered in this course are also relevant for any research or scientific archive. Topics covered are:

  • GxP Records Management Principles
  • Archive-related GxP Regulations
  • The GxP Archivist
  • The GxP Archive
  • Outsourcing GxP Archives

The course is delivered as a one-day training course, or as a series of webinar modules. The webinar modules (corresponding to the topics above) may be booked individually so there is no obligation to complete all five modules. For a more detailed description of the course contents, click here.

Certificates of attendance are provided.

Location and dates – classroom training:

Please contact us to register your interest in attending this course. When we have sufficient numbers, we will contact you to determine the best location and time.

On-demand Webinars:

Please select the link below to access this training programme on demand. Please note that following payment, you will immediately be taken to the webinar recording.  However, you will also receive an registration confirmation email with a join link to enable you to watch the recording at any time.

MODULE 1: Records Management Principles

MODULE 2: Archive-related GxP Regulations COMING SOON

MODULE 3: The GxP Archivist COMING SOON

MODULE 4: The GxP Archive COMING SOON

MODULE 5: Outsourcing GxP Archives COMING SOON

Prices

The classroom course is currently £310 for HSRAA members and £350 for non-members.

The webinars are $110 for each of the five modules. Please note that the training platform we use only provides for charging in US Dollars. The cost is broadly equivalent to £83 or €100, depending on the current exchange rate.